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3 3-D Printing Technologies That Live Up to the Hype

Don’t write off 3-D printing as an overhyped technology just yet. Here are three applications of 3-D printing that could actually reshape medical device manufacturing. Chris Newmarker and Brian Buntz“The future is already here—it's just not very evenly distributed,” wrote influential science fiction author William Gibson.  His words describe the current state of 3-D printing—while it is becoming to be an ever more common tool for prototyping, it’s real potential hasn’t been tapped yet by the medical device industry. But the groundwork has been laid for 3-D printing’s big break.  Consider for instance a new technology called Continuous Liquid Interface Production (CLIP) allows complex objects to emerge out of a pool of resin as though they were the T-1000 emerging from liquid metal in Terminator 2. (The movie actually inspired the technology’s creators.) Or how about University of Louisville professor Stuart Williams’ boasts that it will be possible within our lifetimes to 3-D print complex organs. And already, the use of 3-D printing to make injection molds is allowing the technology to be used for some degree of production rather than mere prototyping.Rob Richards, business development manager for Orchid Design (Shelton, CT) ticks off a number of advantages that 3-D printing brings to medtech: customization and more sophisticated designs that could overcome drawbacks associated with the present death of 3-D printing medtech materials. (Orchid Design is part of Holt, MI–based orthopedic contract manufacturer Orchid.) The DMLS machines that Ortho uses can be precise to within 0.0015 in., while molding or extrusion often has tolerances within 0.005 in., according to Richards. That means 3-D printing is already winning out when it comes to precision.“We’re already more accurate than standard manufacturing tolerances. … Speed is getting better. The cost is getting lower,” Richards says. “It’s only going to get faster and cheaper.” (Find out six reasons from Richards about why 3-D printing will take over medtech.)Here are three things that could make 3-D printing more common in medtech.(function(t,e,n,o){var s,c,i;t.SMCX=t.SMCX||[],e.getElementById(o)||(s=e.getElementsByTagName(n),c=s[s.length-1],i=e.createElement(n),i.type="text/javascript",i.async=!0,i.id=o,i.src=["https:"===location.protocol?"https://":"http://","widget.surveymonkey.com/collect/website/js/0Q5fzA55NV4EA6PaqCts9Izx9ef6RDWoJInYyNXQf7V42MmQ4Gi8AhdnvhV9AcHu.js"].join(""),c.parentNode.insertBefore(i,c))})(window,document,"script","smcx-sdk"); Create your own user feedback survey Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6–7, 2015.Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarkerLike what you’re reading? Subscribe to our daily e-newsletter.

Don’t write off 3-D printing as an overhyped technology just yet. Here are three applications of 3-D printing that could actually reshape medical device manufacturing.

Chris Newmarker and Brian Buntz

“The future is already here—it's just not very evenly distributed,” wrote influential science fiction author William Gibson.  

His words describe the current state of 3-D printing—while it is becoming to be an ever more common tool for prototyping, it’s real potential hasn’t been tapped yet by the medical device industry. But the groundwork has been laid for 3-D printing’s big break.  

Consider for instance a new technology called Continuous Liquid Interface Production (CLIP) allows complex objects to emerge out of a pool of resin as though they were the T-1000 emerging from liquid metal in Terminator 2. (The movie actually inspired the technology’s creators.) Or how about University of Louisville professor Stuart Williams’ boasts that it will be possible within our lifetimes to 3-D print complex organs. And already, the use of 3-D printing to make injection molds is allowing the technology to be used for some degree of production rather than mere prototyping.

Rob Richards, business development manager for Orchid Design (Shelton, CT) ticks off a number of advantages that 3-D printing brings to medtech: customization and more sophisticated designs that could overcome drawbacks associated with the present death of 3-D printing medtech materials. (Orchid Design is part of Holt, MI–based orthopedic contract manufacturer Orchid.) 

The DMLS machines that Ortho uses can be precise to within 0.0015 in., while molding or extrusion often has tolerances within 0.005 in., according to Richards. That means 3-D printing is already winning out when it comes to precision.

“We’re already more accurate than standard manufacturing tolerances. … Speed is getting better. The cost is getting lower,” Richards says. 

“It’s only going to get faster and cheaper.” (Find out six reasons from Richards about why 3-D printing will take over medtech.)

Here are three things that could make 3-D printing more common in medtech.

Create your own user feedback survey

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6–7, 2015.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

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Is Poor Risk Management Holding Your Medtech Company Back?

Is Poor Risk Management Holding Your Medtech Company Back?

Medical device companies can increase efficiency by tightening up their risk management practices.

Jamie Hartford

Efficiency is the name of the game for medical device companies today, and one way for manufacturers to get their products to market faster and at lower cost is to take a close look a their risk management practices.

“Addressing risk management deficiencies is a low-hanging fruit that yields positive results across the board,” says David Amor, managing partner at Medgineering, a Minneapolis-based firm providing remote quality systems, regulatory, remediation, and compliance consulting.

That’s because risk management pervades nearly every step of medical device manufacturing.

“Risk management drives 99% of decisions for medtech companies—from receiving and inspecting product to handling and addressing postmarket deficiencies,” Amor says. “Not having a robust system that impacts so many daily decisions leads to compliance issues, product issues, and quality issues.”

For those that want to tighten up their risk management practices, Amor will be leading a free course, “Practical Risk Management: How to Integrate ISO 14971 into Your Product Development Cycle” from 2–3 p.m. Eastern April 28–30, 2015.

The course, which is sponsored by EtQ, a provider of integrated quality and FDA compliance management software, will focus on the basics of the ISO 14971 standard for application of risk management to medical devices.

The first class will provide an overview of the standard and explain how to integrate it into your company’s product development process and design controls at various stages. Day 2 will spotlight risk analysis techniques such as failure mode and effects analysis and fault tree analysis. The final day of the class will highlight postmarket risk—an especially timely topic because complaint files and poor postmarket surveillance integration with a product’s risk management file have been among the top three findings in FDA warning letters since 2007.

Amor, who has consulted on risk management remediation at several Fortune 500 medtech companies, says integrating risk management remains a struggle for firms of all sizes.

“I see a lot of issues with companies that aren't familiar with how to integrate risk management with non-product development tasks,” he says. “Like we cover in the course, the risk management file should have inputs like complaints, process capability, and new clinical data for products while impacting other quality management system processes like CAPA and supplier controls.”

Amor says those who attend the free class will come away with knowledge they can use to help their companies improve their risk management processes.

“The course is geared towards anybody who wants real, practical information that isn’t ‘Google-able’,” he says. “I reference information from previous risk management remediation projects and break things down in a nutshell so that attendees get actionable insight, not just a listing of ISO 14971 text.” 

Jamie Hartford is MD+DI's editor-in-chief. Reach her at jamie.hartford@ubm.com or on Twitter @MedTechJamie

[image courtesy of DAVID CASTILLO DOMINICI/FREEDIGITALPHOTOS.NET]

 

Analyst: Leadless Pacemaker Adoption Could Be Rapid

Analyst: Leadless Pacemaker Adoption Could Be Rapid

St. Jude Medical, through its Nanostim acquisition, was the first to win regulatory clearance for its leadless pacemaker back in October 2013 in Europe.

Micra leadless pacemaker from Medtronic

Last week, Medtronic announced that it's own version - the Micra leadless pacemaker, the smallest in the world - has obtained CE Mark in Europe. Both products eliminate what many consider the weakest link in heart devices - leads - that have led to several instances of high profile recalls. Both products use a catheter that can deliver the implant instead of requiring a surgical incision to place conventional pacemakers and the creation of a pocket under the skin where those older generation pacemakers can reside.

And now, an analyst report based on a physician survey indicates that adoption of this novel leadless technology may be rapid. RBC Capital Markets conducted a survey of 50 electrophysiologists and an overwhelming 80% showed an interest in using the device, according to a research note from Glenn Novarro, a medtech analyst with the investment bank, on Monday.

Here's more from the note, with slight edits:

Today, [about] 64% of respondents believe leadless pacemakers can capture 0–5% of the US pacemaker market. Five years from now, nearly 70% of respondents believe leadless pacemakers will represent more than 10% of new pacemaker implants. This suggests market adoption could be rapid once a device is introduced into the market....

This should be welcome news to both Medtronic and St. Jude Medical.

The Nannostim Leadless Pacemaker from St. Jude Medical

Medtronic's Micra is implanted in the heart using a catheter snaked through the patient's femoral vein. Once positioned in the right ventricle of the heart, small tines are used to attach the device to the heart wall. Pacing is delivered using an electrode at one end of the pacemaker. Micra is repositionable and retrievable providing another advantage over traditional pacemakers, according to a Medtronic news release announcing the CE Mark. In addition, the leadless pacemaker is fully compatible with MRI scans and has an approximately 10-year battery life. Micra is 30% smaller than its counterpart from St. Jude Medical, a Medtronic spokesman told last year, adding that it can be easily repositioned without causing trauma to the cardiac tissue.

Meanwhile, in an interview in February 2014, when St. Jude Medical announced the first U.S. implant, the company's chief medical officer said that the Nanostim pacemaker can be retrievable over the entire lifetime of the patient, which means that patients don't have to be have two devices - one active and the other inactive - when the patient needs a new device. Mark Carlson, the CMO also declared that the Nanostim's introducer sheath  - the sheath through which the doctors implant the device into the vein - is smaller in diameter than what is required for the Medtronic pacemaker.

Both St. Jude Medical and Medtronic are currently conducting pivotal trials to gain approval in the U.S. St. Jude's trial was designed to enroll 670 patients in medical centers in the US, Canada and Europe. Medtronic's trial is designed to study 780 patients in about 50 centers in 20 countries. 

 Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb 

Stay abreast of industry trends at BioMEDevice Boston, May 6-7 at the Boston Convention & Exhibition Center

Is That OUS Data Good Enough for FDA?

Is That OUS Data Good Enough for FDA?

Marie Thibault

FDA has set out its current thinking about data from clinical studies conducted outside the United States (OUS) in a draft guidance published this week. Though the agency has accepted OUS data to support approvals for years, this guidance provides more detail about factors sponsors should consider and several examples for context.

According to FDA regulation, the agency accepts OUS data from a study with U.S. sites that is carried out under an investigation device exemption (IDE) to support a premarket approval (PMA). FDA also accepts OUS studies for a PMA if the trials were conducted in accordance with the Declaration of Helsinki or the country's laws, if the country's regulations provide for stronger protection of human subjects. The Declaration of Helsinki is a set of ethical principles crafted by the World Medical Association for human medical research. If a sponsor is planning to use exclusively OUS data to try to win PMA approval for a device, they are encouraged to meet with FDA officials before making that PMA submission. 

Agency rules only address OUS studies for PMA applications at this time, though there is a proposed rule from February 2013 that, if finalized, would require OUS studies in support of PMAs and other types of applications (IDEs, humanitarian device exemptions, and 510(k)s) be carried out according to good clinical practice (GCP).

Of course, the OUS data must also provide what FDA calls "valid scientific evidence" in order to support approval. The agency encourages companies to meet with agency officials as early as possible if they are planning to use OUS data for an approval application, because FDA may be able to provide feedback on trial designs and cut down on the need for additional studies.

FDA's draft guidance goes on to detail other considerations sponsors should take into account—differences in clinical conditions, study populations, and regulatory requirements. Finally, the draft guidance reviews seven different situations where OUS data was used to support FDA approval submissions. The examples portray the range of factors the agency considers and offer sponsors better insight into how FDA may view their own situation.  

Stay on top of the latest trends in medtech by attending the MD&M East Conference, June 9–11, 2015, in New York City.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie

[Image courtesy of GREENLEAF DESIGNS/FREEDIGITALPHOTOS.NET]

Dexcom’s Apple Watch-Integrated CGM is Convenient but Won't Change the Game for Diabetics

Dexcom’s Apple Watch-Integrated CGM is Convenient but Won't Change the Game for Diabetics

Yael Grauer

Dexcom's g4 PLATINUM Continuous Glucose Monitoring System will be able to integrate with the Apple Watch.

Users of Dexcom’s G4 PLATINUM Continuous Glucose Monitoring (CGM) System have something to look forward to: the medical device company is integrating its system with the Apple Watch, with plans to expand to both Android and Microsoft in the future.

This is great news for people who want to track their blood sugar levels—or that of a child or loved one—in a way that’s both convenient and discreet.

“There was such a strong call for this that people have created it on their own, so clearly there’s a huge desire for it,” says DiabetesMine community founder Amy Tenderich.

Previously, frustrated patients (and parents of patients) created NightScout, an open-source system that uploads Dexcom’s data to Pebble smartwatches. But unlike NightScout, which has limited appeal outside of its highly technical core audience, Dexcom’s app will be much more accessible to mainstream users.

“In the development of this product, we have spent a lot of time on human practice to make something that is very usable for the majority of people,” says Dexcom chief technology officer Jorge Valdes. The company decided to hitch its wagon to Apple’s star because it anticipates that Apple Watch will be the most popular smartwatch on the market.

This integration has been in the works for quite a while, partially because Dexcom wanted to work out the foundation with FDA. The medical device company worked out an arrangement that would allow it to update the system whenever there’s a new operating system update without needing to get FDA to sign off on it again. Although medical device products typically have a much longer development cycle than consumer products, this arrangement will allow Dexcom to make sure the system is updated regularly.

Valdes notes that patients using Dexcom CGM systems look at their monitors around 50 or 60 times a day on average. Data shows that the more often patients look at their receivers, the better they do at staying in control of their glucose values, he says.

The Apple Watch app will allow users to discreetly and conveniently look at their glucose values, and people with diabetes can share data with up to five other people. Followers will get a notification when something is wrong.

But integrating the CGM system with a smartwatch has limitations. As convenient as it may be, Tenderich cautions people to remember that using this tool won’t revolutionize care.

“We still have diabetes. The data doesn’t do anything except give you more immediate access and the convenience to be able to look at it and to be able to look at someone(’s data) from afar,” she says.

“It’s a way to view data, but it doesn’t change diabetes management,” she adds, although patients (and parents) motivated to wear the watch and use the app will see their data more quickly, and it’s a huge convenience to have it on their wrist.

The Apple Watch can send alarms to alert users when their glucose levels are too high or low, provided they have the Dexcom CGM with them. The smartwarch app is intended as an additional display, not a primary one.

Valdes says Dexcom has plans to integrate with other apps in ways that could be quite useful. For example, the company is working with the Databetes food blog and journal to enable users to share data with Apple’s Healthkit digital health platform and populate the glucose value next to images of food people eat.

Learn more about designing innovative medical devices at the MD&M East conference in New York City June 9–11, 2015.

Yael Grauer is a freelance contributor to MD+DI. Read more of her work at 
http://yaelwrites.com.  

Correction: An earlier version of this story incorrectly stated that when the Dexcom G4 PLATINUM Continuous Glucose Monitoring System is integrated with the Apple Watch, users would be able to leave their Dexcom receivers at home and use the Apple Watch in place of a receiver. In fact, users must have the Dexcom CGM device on them. The previous version also incorrectly stated that the Apple Watch does not include alarms to alert users when their glucose levels are too high or low. In fact, the Apple Watch can send alerts about glucose levels as long as the user has the Dexcom CGM receiver with them.  

 [images courtesy of DEXCOM and APPLE]

DNA Evidence Emerges in Medtech Murder Case

Allison Feldman in an undated photograph released by the Scottsdale police department.
Allison Feldman in an undated photograph released by the Scottsdale police department.

Details continue to slowly be unveiled in in the murder investigation of an Arizona-based sales rep for a Swedish device company.

Brian Buntz

Police in Scottsdale, AZ have obtained a DNA sample and undisclosed physical evidence from a suspect they believe killed Allison Feldman, the 31-year-old medical device sales rep for the Swedish-headquartered device firm, Mölnlycke Health Care. The investigators believe the evidence will help them positively confirm the identity of Feldman's murderer.

Silent Witness, a nonprofit Phoenix-based organization, is now offering a $1000-reward for information that helps close the case.

Police think that that the attacker left Feldman's Scottsdale home at 8526 E. Monterey Way in Scottsdale at approximately 1 a.m. on February 18. There were no signs of forced entry.

Her body was discovered on the afternoon of February 18 by Feldman's boyfriend, Alex Sukhodolov, who phoned the police at 4:02 p.m. He has not been named by police as a person of interest. He has, however, been questioned by local police multiple times and provided a DNA sample to police.

Police are currently looking for a suspect that was unaccounted for from late in the night on February 17 to after 1 a.m. on February 18. The suspect also may have in his possession Feldman's credit card, iPhone 6, jewelry, and a Tiffany's bracelet, which were believed to be stolen from Feldman's home the night of the murder. Police also believe that the attacker may have lived in the area

According to a statement from police, the subject may not always be violent, but could become violent when confronted. He likely suffered minor cuts or injuries to his hands or arms struggling with Allison.

In addition to the iPhone and credit cards, he may have taken a Tiffany bracelet and other jewelry.

Feldman suffered cranial trauma and was found by her boyfriend lying naked in a pool of her own blood. 

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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Decades-Old Coating Helps Usher in New Diagnostics Era

Microfluidics and smartphone-based applications mean SurModics' decades-old StabilCoat is stretching its legs in new ways.

Chris Newmarker

Sia HIV device
An inexpensive smartphone compatible device out of Columbia University could detect HIV and syphillisSurModicsStabilCoat helped enable make Columbia's assays more durable and capable of withstanding high heat and humidity.

Columbia University researchers did not have a run-of-the mill IVD device in mind when they approached SurModics early last year about using its StabilCoat for preserving proteins in immunoassays.

The Columbia device plugged into a smartphone and used a vacuum created by a compressed rubber bulb to move a single finger prick of blood through microchannels where various assays tested the blood for HIV and syphilis.

"They invented a brand new mousetrap," says Drew Pauly, director of in vitro diagnostics product development at the Eden Prairie, MN-based company. (Read a full Qmed story about the device here.)

Pauly, SurModics scientist Sean Lundquist and others at the company worked on and off with the Columbia researchers for about six months to ensure that the StabilCoat helped the proteins in immunoassays stand up to the hot and humid conditions of Rwanda, where the Columbia researches intended to test out the device.

The story provides a great example of how the shift to lab on a chip and other point-of-care IVD technologies are changing the game for companies in the diagnostics coatings business, where established IVD coating technologies are helping improve the performance of contemporary diagnostics.

The situation is resulting in a new chapter for StabilCoat, a decades-old coating made from a proprietary SurModics formulation that includes a bovine protein and other components. It is used to preserve proteins in an assay, and to block out other reactions with the blood that would cloud the results.

The coating helped the Columbia researchers create a lab on a chip that lives up to its name. "They're getting lab-quality results without the walls of a laboratory around them," Pauly said.

Lundquist says much of their time was spent helping the Columbia researchers figuring out the humidity levels and time period during which their manufacturing robots needed to apply the StabilCoat. Proper packaging to ensure the StabilCoat would last was also important.

"We tweaked some of the drying conditions. That was a big factor. And then there was also removing residual from channels. We worked with them on the best way to do that," Lundquist said.

"There's not an application note that you can find in the public domain for, 'How do I coat my microchannels?'" Pauly said. "As Sean indicated, it was giving them a starting place. 'Here's where we've typically started with building an assay. So here are some drying times. Here are some [humidity levels], some temperatures and durations for getting that to ... stay stabilized."

Such consultations are becoming increasingly commonplace for SurModics because a whole host of companies are seeking to get IVD out of laboratories and out into doctors' offices and other healthcare settings.

The standard for laboratory-based IVD has been polystyrene 96-well plates, Pauly says. "One well of that is a pretty big swimming pool for an assay to occur."

Now there are devices with microchannels with new geometries and tiny dimensions. "Surface energies change," Pauly says. 

The situation means that channels could become clogged with proteins in certain situations, requiring other surface-modifying coatings.

Another challenge for Pauly, Lundquist and others at SurModics involves new materials: IVD device designers are also moving away from polystyrene and using moldable plastics such as cyclic olefin copolymer (COC) or polydimethylsiloxane PDMS that allow for more complex geometries.

The situation means there are plenty of puzzles for SurModics to figure out around use of StabilCoat these days. The overall goal is to make sure it continues to do what it has done so well for decades. "You're taking a biologic out of the body, a protein that doesn't like being outside of the environment. How do you keep it happy, active, available to do its job in the assay and detect disease? ... That's been the challenge for diagnostics since the earliest pregnancy assays," Pauly said.
 

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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How Insects Inspired New Hearing Aid Microphones

Researchers are in the midst of developing a new hearing aid with a directional microphone designed to eliminate unwanted background noise -- similar to the ear of an insect.

Kristopher Sturgis

Mussel- and gecko-inspired adhesives, artificial blood vessels made of spider silk, cuttlefish-inspired ingestible sensors... There have been plenty of research breakthroughs over the years that have been inspired by nature. Researchers from Glasgow decided to run with the same approach when developing hearing aid technology--by looking to insects. The resulting microphone technology helps locate specific sounds while eliminating background noise picked up by directional microphones.

Microphone technology has progressed slowly, remaining largely unchanged for decades. Current directional microphone technology often adds weight and power requirements that drive up the cost of production.

James Windmill, PhD, one of the lead researchers on the new hearing aid system, spoke about the genesis of the idea and how the new hearing aid system can improve current technologies.

"The idea of taking inspiration from insect ears has been around since the 1990's," Windmill explains. "I've been exploring insect hearing and looking at what we can learn from it. At Strathclyde, we have tried not to mimic the insect ear, but rather take the basics of how the insect ear works. We then looked at different things based on them. In particular, there are specific characteristics that we are interested in to make the technology practical for humans."

Windmill says that current hearing aid technologies excel at audibility, but are only partially successful at providing intelligibility in noisy situations. With this conventional technology, acoustic directionality is important, so a target sound is ideally located in front of the user.

"A hearing aid currently only gets its directionality -- its ability to attenuate sounds coming from particular directions -- by having two ports or two separate mics spaced approximately 10 millimeters apart," Windmill says. "This new microphone is directional in a singular miniature device, and has the potential to work not just along the axis of the two ports in conventional aids. Therefore, this mic design could finally deliver on what drives people to seek out help, making it a huge step forward in providing hearing assistance.

Many challenges still remain, however, including the development of a directional microphone that is as sensitive to sound as a standard microphone.

"We are getting close to solving that," Windmill says. "This three year project is designed to take our lab based designs and see what we need, to push them toward something that would be useful in a hearing aid. We're not the only ones looking at this sort of technology, but as far as I know, there are no hearing aids with this kind of technology yet."

A fact Windmill and his group are hoping to change as their research progresses. The group remains pretty tight lipped on their plans to advance the technology in the near future, but their objective remains clear. Windmill and his team intend to continue exploring insect hearing in the hopes that with careful research, we can use what we learn to enhance microphone technology in our own hearing systems, all in an effort to help those affected by hearing loss in new innovative ways. 

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

Kristopher Sturgis is a contributor to Qmed and MPMN.

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Are These Medical Devices Safe? (Breast Implants)

Are These Medical Devices Safe? (Breast Implants)

Breast Implants

In January 2011, FDA issued a report saying it was aware of a potential association between breast implants and anaplastic large cell lymphoma (ALCL), a very rare form of cancer. At that time, the agency said it was aware of approximately 60 ALCL cases in patients with breast implants. FDA went on to say that it believes implant patients may have a slightly increased risk of developing ALCL in a scar capsule next to the breast implant.

Industry Says:

A woman is more likely to be struck by lightning than get this condition. Patients' safety is Allergan's absolute first priority and we continue all efforts to collect and analyze further information about the very rarer occurrence of ALCL in patients with breast implants.”

—Caroline Van Hove, spokeswoman for Allergan, maker of breast implants, in an e-mailed statement quoted by Bloomberg in a 2011 article.

Women with breast implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL, in the scar tissue and fluid adjacent to the implant. ALCL is not breast cancer—it is a rare type of non-Hodgkin's lymphoma (cancer of the immune system). ALCL has been reported globally in patients with an implant history that includes Mentor's and other manufacturers' breast implants.”

—Excerpt from a 2013 patient brochure for Mentor breast augmentation product. Mentor

 

Activists Say:

Four hundred people are injured or killed by lightning every year. ALCL may strike fewer women but it is an avoidable risk that most of us would choose to steer clear of, just as we do not go swimming during a thunderstorm. In addition, it is possible that there may be more cases of ALCL than have been reported.”

Maura Duffy, in a January 2014 posting on the Web site for the Cancer Prevention and Treatment Fund

FDA Says:

Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. At this time, data appear to indicate that the incidence of ALCL is very low, even in breast implant patients. Currently it is not possible to identify a type of implant (silicone versus saline) or a reason for implant (reconstruction versus aesthetic augmentation) associated with a smaller or greater risk.” 

—Excerpt from FDA's January 2011 report, "Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses." 

 

FDA Actions:

2011: Issued a preliminary report on the potential association between ALCL and breast implants. Also announced it would collaborate with the American Society of Plastic Surgeons and other experts to develop a registry to capture these patients.

 

[Image courtesy of Mentor Worldwide LLC]

da Vinci Surgical Robot Medtech Miracles and Tragedies

Are These Medical Devices Safe? (da Vinci Surgical System)

Are These Medical Devices Safe? (da Vinci Surgical System)

da Vinci Surgical System

Robotic surgery seems to be the way of the future—every other industry is becoming automated, so why not surgery? Intuitive Surgical has been the leader in the robotic surgery field with its da Vinci Surgical System. Proponents believe experienced users can get better results because robotic surgery removes the shake from surgeon hands, can access hard-to-reach areas, and can potentially result in less pain and shorter hospital stays. 

However, in recent years, several media outlets have reported on complications patients claim to have experienced during robotic surgery with Intuitive Surgical's da Vinci Surgical System. Alleged incidents range from burns and perforations to death. An article published in 2013 in the Journal for Healthcare Quality found that complications with the system were underreported to FDA.

Also in 2013, Bloomberg reported that FDA began surveying surgeon users of the da Vinci system on complications they have observed and for which procedures the system should and shouldn't be used. In July 2013, FDA sent Intuitive Surgical a warning letter, admonishing the company for failing to make timely reports about field corrections to the agency. This warning letter was resolved in April 2014. 

Activists Say:

"The rapid adoption of robotic surgery...has been done by and large without the proper evaluation.”

—Martin Makary MD, MPH, in a quote from a New York Daily News article about robotic surgery. Makary also co-authored the Journal for Healthcare Quality article on underreporting of complications.

Industry Says:

"Because a medical device manufacturer can only report an adverse event to the FDA after it is notified of the event, and because that notification may not be received until months or even years from the time of the event, a MAUDE [Manufacturer and User Facility Device Experience] database entry with a relatively recent reporting date may be associated with an adverse event that occurred much farther in the past...Thus, any assessment of safety trends based on Reporting Dates rather than Event Dates in the MAUDE database will be fundamentally flawed and misleading, and is likely to seriously misrepresent the true performance of a device.”

Excerpt from a November 25, 2013 Intuitive Surgical statement on its analysis of Medical Device Reporting trends showing a decline in the overall adverse event rate

 

FDA Actions:

2013: Surveyed surgeons on their experience with robotic surgery complications and types of procedures.

2013: Issued a warning letter to Intuitive Surgical on its failure to make timely reports to FDA about prior field actions.

2014: Closed out the warning letter.

The da Vinci S Surgical System

[Image courtesy of Intuitive Surgical Inc.]

Essure Permanent Birth Control Breast Implants